DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant amendment filed 08/28/2025 has been entered and is currently under consideration. Claims 1-27 remain pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-27 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites two or more predetermined geometric indentations in the front and back. It is not clear if there are two or more predetermined geometric indentations on each of the front and back lens surface or if the total amount of predetermined geometric indentations on the front and back equal two or more. For the purpose of compact prosecution, the claim has been interpreted to mean the total amount of predetermined geometric indentations on the front and back equal two or more.
Claims 11 is rendered indefinite because it is not clear if there is at least two recess on each of the front and back lens surface or if the total amount of recesses on the front and back equal at least two. Claim 11 is further rendered indefinite because it is not clear if the at least one recess is the same or different from the two or more predetermined geometric indentations of claim 1. For the purpose of compact prosecution, the claim has been interpreted to mean that the two or more predetermined geometric indentations are the same as the at least two recess and the total amount of recesses on the front and back equal at least two.
Claims 12 and 14 recite the at least one recess. The claim is rendered indefinite because it is not clear which recess is being referenced by the claims. The examiner notes that the issue was introduced by the amendment to claim 11 from which the claims depend.
Claim 16 recites two or more predetermined geometric indentations in the front and back. It is not clear if there are two or more predetermined geometric indentations on each of the front and back lens surface or if the total amount of predetermined geometric indentations on the front and back equal two or more. For the purpose of compact prosecution, the claim has been interpreted to mean the total amount of predetermined geometric indentations on the front and back equal two or more.
All claims dependent on the above rejected claims are rejected as well because they include all the limitations of the rejected claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 8-12, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scales et al. (US2019/0233573 of record) hereinafter Scales in view of Widman et al. (US2009/0051059 of record) hereinafter Widman '059.
Regarding claim 1, Scales teaches:
A method for forming an ophthalmic lens ([0002]), the method comprising:
providing a mold assembly including a base curve mold and a front curve mold (Fig 1: surface 140, reservoir 150; [0092-0093]), each having a surface profile (Fig 1), the base curve mold and the front curve mold defining and enclosing a cavity therebetween (Fig 1), the cavity containing a reactive monomer mixture comprising a monomer suitable for making the ophthalmic lens (Fig 1: liquid 145; [0093, 0103-0104]) and a first polymerization initiator that is capable of being activated at a first wavelength ([0096-0097]), wherein at least one of the base curve mold or front curve mold is light transmissive ([0095]);
exposing the at least one light transmissive base or front curve mold to a source of substantially uniform actinic radiation at the first wavelength according to a predetermined exposure pattern including at least one exposure portion and at least one non-exposure portion to initiate polymerization of the reactive monomer mixture within the mold at said at least one exposure portion ([0097]);
exposing said at least one exposure portion to said source of actinic radiation until the lens is fully cured at said exposure portions ([0097]);
wherein the at least one non-exposure portion is selected such that, upon full curing of the at least one exposure portion, unreacted or non-gelled portions remain within the lens adjacent to the front and base mold halves ([0098]);
removing the ophthalmic lens from the mold assembly (implicit); and
extracting said unreacted and non-gelled portions ([0098]).
Scales does not teach two or more predetermined geometric indentations in the front and back surfaces of the lens.
In the same field of endeavor regarding lens formation, Widman ‘059 teaches two or more predetermined geometric indentations in the front and back surfaces of the lens for the motivation of producing a surface of a quality ophthalmic lens device (Fig 4: concentric circular lines 410; [0244]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the lens as taught by Scales with the features as taught by Widman ‘059 in order to produce a surface of a quality ophthalmic lens device.
Scales further teaches a surface profile of the respective front and back mold halves (Fig 1). Scales further teaches using selective radiation to form the shape of lens ([0097-0098]) in a reservoir formed by the front and back mold halves. Inherently, any shape that is not in the shape of the reservoir deviates from the surface profile of the respective front and back mold halves.
It would be apparent to one of ordinary skill that the prior art teaches two or more predetermined geometric indentations in the front and back surfaces of the lens such that the surface profile of the lens deviates from the surface profile of the respective front and back mold halves at the locations of the geometric indentations.
Regarding claim 8, Scales in view of Widman ‘059 teaches the method of claim 1.
Scales further teaches wherein the first wavelength is in the range of 380 to 450 nm ([0088]).
Regarding claim 9, Scales in view of Widman ‘059 teaches the method of claim 8.
Scales further teaches wherein the first wavelength is approximately 420 nm ([0088]).
Regarding claim 10, Scales in view of Widman ‘059 teaches the method of claim 1.
Scales further teaches wherein the ophthalmic lens is a hard contact lens, a soft contact lens, a hybrid contact lens, a rigid gas permeable contact lens, or an intraocular lens ([0031]).
Regarding claim 11, Scales in view of Widman ‘059 teaches the method of claim 1.
Scales further teaches forming a fully cured lens by extracting unreacted and non-gelled portions ([0098]).
Widman ’059 further teaches the lens includes at least two recesses at a front and back surface of the lens (Fig 4: concentric circular lines 410; [0244]).
Regarding claim 12, Scales in view of Widman ‘059 teaches the method of claim 11.
Widman ‘059 further teaches wherein the at least two recesses further comprises a plurality of substantially round recesses (Fig 4: concentric circular lines 410; [0244]).
Regarding claim 14, Scales in view of Widman ‘059 teaches the method of claim 11.
Widman ‘059 further teaches wherein the at least two recesses further comprises a longitudinal channel (Fig 4: drain channels 420; [0200, 0245]).
Claim(s) 2-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scales in view of Widman ‘059 as applied to claim 1 above, and further in view of Widman (2012/0187589 of record) hereinafter Widman.
Regarding claim 2, Scales in view of Widman ‘059 teaches the method of claim 1.
Scales further teaches the source of actinic radiation is a selectively controllable actinic radiation source and in the at least one exposure portion the selectively controllable actinic radiation source directs said actinic radiation onto said transmissive mold half, and in the at least one non-exposure portion the selectively controllable actinic radiation source does not direct said actinic radiation onto said transmissive mold half ([0097]).
Scales in view of Widman ‘059 does not teach wherein the source of actinic radiation includes a plurality of selectively controllable beams of actinic radiation and in the at least one exposure portion the plurality of selectively controllable beams direct said actinic radiation onto said transmissive mold half, and in the at least one non-exposure portion the plurality of selectively controllable beams do not direct said actinic radiation onto said transmissive mold half.
However, Scales teaches using a DMD as described in Widman ([0097]).
In the same field of endeavor regarding lens formation, Widman teaches a source of actinic radiation comprising a DMD that directs a plurality of selectively controllable beams of actinic radiation onto a transmissive mold half (Fig 5; [0009, 0093-0098]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method as taught by Scales in view of Widman ‘059 to use the DMD as taught by Widman since Scales teaches that the DMD of Widman is a suitable DMD.
Regarding claim 3, Scales in view of Widman ‘059 teaches the method of claim 1.
Scales further teaches the source of actinic radiation is a selectively controllable actinic radiation source and in the at least one exposure portion the selectively controllable actinic radiation source directs said actinic radiation onto said transmissive mold half ([0097]).
Scales in view of Widman ‘059 does not teach wherein the source of actinic radiation includes a plurality of selectively controllable beams of actinic radiation and in the at least one exposure portion the plurality of selectively controllable beams direct said actinic radiation onto said transmissive mold half, and in the at least one non-exposure portion the plurality of selectively controllable beams direct said actinic radiation onto said transmissive mold half according to a predetermined gray scale pattern.
In the same field of endeavor regarding lens formation, Widman teaches a source of actinic radiation comprising a DMD that directs a plurality of selectively controllable beams of actinic radiation onto a transmissive mold half (Fig 5; [0009, 0093-0098]) and exposing a second portion of a volume of reactive mixture to a second actinic radiation using gray scale pattern for the motivation of forming an area of the lens having a different index of refraction ([0072]; claim 1).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method as taught by Scales in view of Widman ‘059 to use the DMD as taught by Widman since Scales teaches that the DMD of Widman is a suitable DMD and to have modified the method as taught by Scales in view of Widman ‘059 with the second exposure using a gray scale pattern as taught by Widman in order to form an area of the lens having a different index of refraction.
Regarding claim 4, Scales in view of Widman ‘059 and Widman teaches the method of claim 3.
Widman further teaches wherein the plurality of beams of actinic radiation are selectively controlled by a digital micro-mirror device according the predetermined exposure pattern (Fig 5; [0009, 0093-0098]).
Regarding claim 5, Scales in view of Widman ‘059 and Widman teaches the method of claim 4.
Widman further teaches wherein the digital micro-mirror device includes an illumination source containing at least one light emitting diode ([0106]).
Regarding claim 6, Scales in view of Widman ‘059 and Widman teaches the method of claim 3.
Widman further teaches wherein the plurality of beams of actinic radiation are selectively controlled by a static mask with a predetermined exposure pattern ([0072]).
Regarding claim 7, Scales in view of Widman ‘059 and Widman teaches the method of claim 3.
Widman further teaches wherein the plurality of beams of actinic radiation are selectively controlled by a static mask with a predetermined exposure pattern which includes regions of partial transmission ([0072]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scales in view of Widman ‘059 as applied to claim 12 above, and further in view of Franklin et al. (US9927633 of record) hereinafter Franklin.
Regarding claim 13, Scales in view of Widman ‘059 teaches the method of claim 12.
Scales in view of Widman ‘059 does not teach wherein the plurality of substantially round recesses are placed in at least one predetermined portion of the lens, and wherein said predetermined portion has a different surface friction than the remainder of the lens.
However, Widman ‘059 teaches that the recesses are located in the optical zone (Fig 4; [0244]).
In the same field of endeavor regarding lens formation, Franklin teaches utilizing a friction zone having a coefficient of friction differential from the reminder of the lens in the periphery of the optical zone of a lens for the motivation of orienting and stabilizing a lens on eye (Fig 5: surface modified zone 506; col 4, ln 21-col 5, ln 8; col 10, ln 36-53).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the lens as taught by Scales in view of Widman ‘059 with the friction zone as taught by Franklin in order to orient and stabilize a lens on eye.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scales in view of Widman ‘059 as applied to claim 1 above, and further in view of Seiderman (US4068933 of record).
Regarding claim 15, Scales in view of Widman ‘059 teaches the method of claim 1.
Scales in view of Widman ‘059does not teach wherein following the extraction step the fully cured lens include at least one fenestration through the lens extending between the front and back surface of the lens.
In the same field of endeavor regarding contact lenses, Seiderman teaches providing fenestrated lenses for the motivation of promoting fluid and oxygen permeability (col 1, ln 49-52; col 2, ln 43-46).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the lens as taught by Scales in view of Widman ‘059 with the fenestrations as taught by Seiderman in order to promote fluid and oxygen permeability.
Claim(s) 16-25 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scales in view of Widman '059 and Widman.
Regarding claim 16, Scales teaches:
A method for forming an ophthalmic lens ([0002]), the method comprising:
providing a mold assembly including a base curve mold and a front curve mold (Fig 1: surface 140, reservoir 150; [0092-0093]), each having a surface profile (Fig 1), the base curve mold and the front curve mold defining and enclosing a cavity therebetween (Fig 1), the cavity containing a reactive monomer mixture comprising a monomer suitable for making the ophthalmic lens (Fig 1: liquid 145; [0093, 0103-0104]), a first polymerization initiator that is capable of being activated at a first wavelength ([0096-0097]), and a UV blocker ([0262]), wherein at least one of the base curve mold or front curve mold is light transmissive ([0095]);
exposing the at least one light transmissive base or front curve molds to a source of substantially uniform actinic radiation at a first wavelength within said first range according to a predetermined exposure pattern, including at least one primary exposure portion to initiate polymerization of the reactive monomer mixture within the mold at said at least one primary exposure portion, wherein said primary exposure portions are exposed to said first wavelength until the lens is fully cured at said primary exposure portions ([0097]);
removing the ophthalmic lens from the mold assembly (implicit); and
extracting uncured and non-gelled portions from the lens ([0098]).
Scales does not teach two or more predetermined geometric indentations in the front and back surfaces of the lens.
In the same field of endeavor regarding lens formation, Widman ‘059 teaches two or more predetermined geometric indentations in the front and back surfaces of the lens for the motivation of producing a surface of a quality ophthalmic lens device (Fig 4: concentric circular lines 410; [0244]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the lens as taught by Scales with the features as taught by Widman ‘059 in order to produce a surface of a quality ophthalmic lens device.
Scales further teaches a surface profile of the respective front and back mold halves (Fig 1). Scales further teaches using selective radiation to form the shape of lens ([0097-0098]) in a reservoir formed by the front and back mold halves. Inherently, any shape that is not in the shape of the reservoir deviates from the surface profile of the respective front and back mold halves.
It would be apparent to one of ordinary skill that the prior art teaches two or more predetermined geometric indentations in the front and back surfaces of the lens such that the surface profile of the lens deviates from the surface profile of the respective front and back mold halves at the locations of the geometric indentations.
Scales in view of Widman ‘059 does not teach at least one secondary exposure portion and
(c) exposing the at least one light transmissive base or front curve molds at said at least one secondary exposure portions to a source of substantially uniform actinic radiation at a second wavelength that is at least partially attenuated by said UV blocker to initiate polymerization of the reactive monomer mixture within the mold assembly, wherein exposure at said secondary exposure portions is at a predetermined time and intensity so as not to fully cure the lens at said secondary exposure portions;
In the same field of endeavor regarding lens formation, Widman teaches at least one secondary exposure portion (claim 1) and
(c) exposing the at least one light transmissive base or front curve molds at said at least one secondary exposure portions to a source of substantially uniform actinic radiation at a second wavelength that is at least partially attenuated by said UV blocker to initiate polymerization of the reactive monomer mixture within the mold assembly, wherein exposure at said secondary exposure portions is at a predetermined time and intensity so as not to fully cure the lens at said secondary exposure portions for the motivation of forming an area of the lens having a different index of refraction ([0072; 0186]; claim 1 the fluent reactive media requires washing, implying that all the material is not fully cured).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method as taught by Scales in view of Widman ‘059 to use the DMD as taught by Widman since Scales teaches that the DMD of Widman is a suitable DMD and to have modified the method as taught by Scales in view of Widman ‘059 with the second exposure using a gray scale pattern as taught by Widman in order to form an area of the lens having a different index of refraction.
Regarding claim 17, Scales in view of Widman ’059 and Widman teaches the method of claim 16.
Widman further teaches wherein the source of actinic radiation includes a plurality of selectively controllable beams of actinic radiation that direct said actinic radiation onto said transmissive front or back curve mold when in an "on" position and do not direct said actinic radiation onto said transmissive front or back curve mold when in an "off" position (Fig 5; [0009, 0093-0098]).
Regarding claim 18, Scales in view of Widman ’059 and Widman teaches the method of claim 17.
Widman further teaches wherein the plurality of beams of actinic radiation are selectively controlled by a digital micro-mirror device according the predetermined exposure pattern (Fig 5; [0009, 0093-0098]).
Regarding claim 19, Scales in view of Widman ’059 and Widman teaches the method of claim 18.
Widman further teaches wherein the digital micro-mirror device includes an illumination source containing at least one light emitting diode ([0106]).
Regarding claim 20, Scales in view of Widman ’059 and Widman teaches the method of claim 17.
Widman further teaches wherein the plurality of beams of actinic radiation are selectively controlled by a static mask with a predetermined exposure pattern which includes regions of partial transmission ([0072]).
Regarding claim 21, Scales in view of Widman ’059 and Widman teaches the method of claim 16.
Scales further teaches wherein the first wavelength is in the range of 380 to 450 nm ([0088]).
Regarding claim 22, Scales in view of Widman ’059 and Widman teaches the method of claim 21.
Scales further teaches wherein the first wavelength is approximately 420 nm ([0088]).
Regarding claim 23, Scales in view of Widman ’059 and Widman teaches the method of claim 22.
Widman further teaches wherein the second wavelength is approximately 365 nm ([0116]).
Regarding claim 24, Scales in view of Widman ’059 and Widman teaches the method of claim 16.
Scales further teaches wherein the ophthalmic lens is a hard contact lens, a soft contact lens, a hybrid contact lens, a rigid gas permeable contact lens, or an intraocular lens ([0031]).
Regarding claim 25, Scales in view of Widman ’059 and Widman teaches the method of claim 16.
Scales further teaches forming a fully cured lens by extracting unreacted and non-gelled portions ([0098]).
Widman ’059 further teaches the lens includes at least one recess at a front and back surface of the lens, wherein the at least one recess is formed from the two or more predetermined geometric indentations (Fig 4: concentric circular lines 410; [0244]).
Regarding claim 27, Scales in view of Widman ’059 and Widman teaches the method of claim 25.
Widman ‘059 further teaches wherein the at least one recess further comprises a longitudinal channel (Fig 4: drain channels 420; [0200, 0245]).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scales in view of Widman ‘059 and Widman as applied to claim 16 above, and further in view of Franklin.
Regarding claim 26, Scales in view of Widman ’059 and Widman teaches the method of claim 16.
Widman ‘059 further teaches wherein a plurality of substantially round recesses form from at least a portion of the two or more predetermined geometric indentations (Fig 4: concentric circular lines 410; [0244])
Scales in view of Widman ’059 and Widman does not teach wherein the plurality of substantially round recesses are placed in at least one predetermined portion of the lens, and wherein said predetermined portion has a different surface friction than the remainder of the lens.
However, Widman ‘059 teaches that the recesses are located in the optical zone (Fig 4; [0244]).
In the same field of endeavor regarding lens formation, Franklin teaches utilizing a friction zone having a coefficient of friction differential from the reminder of the lens in the periphery of the optical zone of a lens for the motivation of orienting and stabilizing a lens on eye (Fig 5: surface modified zone 506; col 4, ln 21-col 5, ln 8; col 10, ln 36-53).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the lens as taught by Scales in view of Widman ’059 and Widman with the friction zone as taught by Franklin in order to orient and stabilize a lens on eye.
Response to Arguments
Applicant’s arguments filed 08/28/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
For at least the above reasons, the application is not in condition for allowance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER A WANG whose telephone number is (571)272-5361. The examiner can normally be reached M-Th 8 am-4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alison Hindenlang can be reached at 571-270-7001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER A WANG/Examiner, Art Unit 1741
/JACOB T MINSKEY/Primary Examiner, Art Unit 1748
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